Topical Cannabidiol Application and Skin Vascular Reactivity

NCT ID: NCT05456113

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-10-01

Brief Summary

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Cannabidiol, or CBD, is an over-the-counter "nutraceutical" that is more commonly being used by healthy adults for pain management, recovery from strenuous exercise, and general wellness. However, little research exists on the effects of CBD in otherwise healthy individuals. This study uses iontophoresis, a common technique used in physical therapy, to determine the effectiveness of topical CBD in lessening the reflex increased cutaneous vascular conductance response to stimulation of the skin.

Detailed Description

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Conditions

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Effect of Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Vehicle control, does not contain cannabidiol

Group Type PLACEBO_COMPARATOR

Cannabidiol

Intervention Type BIOLOGICAL

Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine

Cannabidiol

Active ingredient experimental arm, contains full spectrum connabidiol

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type BIOLOGICAL

Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine

Interventions

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Cannabidiol

Urbal Activ Extra Strength CBD Body Strong Balm applied to region of forearm to be stimulated by iontophoresis machine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Men and women 18 years of age and older
* English speaking
* Non-obese class III, BMI ≤ 39.9
* Normal HbA1C of \<6.5%

Exclusion Criteria

* Abnormal resting heart rate (\<60 or \>100 bpm) or BP (systolic \<100 or \>129 mmHg, diastolic \<60 or \>100 mmHg) values
* Rash, skin disease, disorders of pigmentation
* Known skin allergies
* Diabetes
* Nicotine use (e.g. smoking, chewing tobacco, vaping, etc.)
* Illegal drug use
* Recent (within the last 30 days) CBD users either topical or oral
* Allergy or hypersensitivity to investigational agents
* Women who are pregnant or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Lacy Alexander

Professor of Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Noll Laboratory

University Park, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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20515

Identifier Type: -

Identifier Source: org_study_id

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